Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments

BIO's response to HHS Request for Information:…

Below is BIO's formal response to the Department of Health and Human Services' (HHS) request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making

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HHS TrialBlazer: BIO Comment Letter – FDA 2019-D…

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HHS TrialBlazer: PhRMA-BIO Comment Letter – OIG…

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BIO Comments on OMB Proposed Rule "Regulation for Federal Financial Assistance"

July 13, 2026

BIO Testimony on “Medicines and IP: Balancing Innovation and Access” to the Subcommittee on Intellectual Property, Artificial Intelligence, and the Internet

June 4, 2026

BIO Letter of Support for SECURE Data Act

June 4, 2026

BIO Comments on DoL Proposed Rule, “Improving Transparency into Pharmacy Benefit Manager Fee Disclosure”

April 15, 2026

John F. Crowley's Annual Letter to BIO Membership

April 8, 2026

Dear Colleagues, I am just past the two-year mark as BIO’s President & CEO, which arrives as we find ourselves at a defining moment for the future of biotechnology. For fifty years, our industry has delivered one of the great…

BIO Comments on Global Benchmark for Efficient Drug Pricing (GLOBE) Model (CMS-5545-P)

February 23, 2026

BIO Comments on Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546-P)

February 23, 2026

Testimony of John F. Crowley President and CEO, BIO House Committee on Energy and Commerce Subcommittee on Health Hearing on “Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain"

February 11, 2026

Chairman Griffith, Chairman Guthrie, Ranking Member DeGette, Ranking Member Pallone, and distinguished members of the subcommittee, thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO)…

Letter From BIO President & CEO John F. Crowley to Senate and House Leadership on GLOBE GUARD

February 9, 2026

Dear Mr. Thune, Mr. Schumer, Mr. Johnson, and Mr. Jeffries:As President and CEO of the Biotechnology Innovation Organization (BIO), as a father and entrepreneur whose family is here today because of biotech innovation, and on behalf of the more than…

CSBA Letter to Congressional Leaders on PBM, PPRV, and SBIR

December 8, 2025

Dear Congressional Leaders:On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to…